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Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
This study is enrolling participants by invitation only.
Sponsor:
Pharmacyclics LLC.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01109069
First received: April 19, 2010
Last updated: April 11, 2017
Last verified: April 2016
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Purpose
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
| Condition | Intervention | Phase |
|---|---|---|
| B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-differentiated Lymphocytic Lymphoma B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Non-Hodgkin's Lymphoma Waldenstrom Macroglobulinemia Burkitt Lymphoma B-Cell Diffuse Lymphoma | Drug: PCI-32765 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. |
Resource links provided by NLM:
Drug Information available for:
Ibrutinib
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
B-cell Lymphoma
Mantle Cell Lymphoma
Waldenstrom Macroglobulinemia
Follicular Lymphoma
Burkitt Lymphoma
U.S. FDA Resources
Further study details as provided by Pharmacyclics LLC.:
Primary Outcome Measures:
- Adverse Events/ Safety Tolerability [ Time Frame: 30 days after last dose of study drug ]Frequency, severity, and relatedness of adverse events
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Frequency of tumor assessments done per standard of care ]Tumor response will be assessed per established response criteria. This study will capture time to progression-free survival
- Duration of Response [ Time Frame: Time to disease progression ]Duration of response as measured by established response criteria for B cell lymphoma and chronic lymphocytic leukemia
- Overall Survival [ Time Frame: Every 3 months (±7 days) until the end of study ]After disease progression, attempts to follow for subject survival status (including cause of death) by clinic visit, or phone contact as well as collection of subsequent anti cancer therapy should be performed once every 3 months (±7 days) until the end of study.
- Tolerability [ Time Frame: 30 days after last dose of study drug ]Long term tolerability as measured by treatment related SAEs and discontinuation of study treatment due to AEs.
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PCI-32765 |
Drug: PCI-32765
Dose based on parent protocol
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
- Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion Criteria:
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
- Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
- Lactating or pregnant
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109069
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109069
Locations
| United States, California | |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| New Hyde Park, New York, United States, 11042 | |
| New York, New York, United States, 10065 | |
| Rochester, New York, United States, 14642-0001 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Springfield, Oregon, United States, 97477 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Tyler, Texas, United States, 75702 | |
| United States, Vermont | |
| Burlington, Vermont, United States, 05405 | |
| United States, Washington | |
| Vancouver, Washington, United States, 98684 | |
| Yakima, Washington, United States, 98902 | |
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
| Study Director: | Alvina Chu, MD | Medical Monitor |
More Information
Additional Information:
| Responsible Party: | Pharmacyclics LLC. |
| ClinicalTrials.gov Identifier: | NCT01109069 History of Changes |
| Other Study ID Numbers: |
PCYC-1103-CA PCI-32765 ( Other Identifier: Pharmacyclics ) |
| Study First Received: | April 19, 2010 |
| Last Updated: | April 11, 2017 |
Keywords provided by Pharmacyclics LLC.:
|
PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Lymphoma, Follicular Lymphoma, Non-Hodgkin Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Burkitt Lymphoma Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Leukemia, B-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on August 18, 2017